BEUDAMED
    FDA Recall Terminated

    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01

    Recall: Z-1473-2017 · Initiated February 8, 2017

    Recall

    Recall Number
    Z-1473-2017
    Event Number
    76497
    Firm
    Medtronic
    FEI Number
    1219930
    Product Code
    FCG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 8, 2017
    Posted
    February 28, 2017
    Terminated
    July 18, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01

    Reason

    Handle may break during use.

    Action

    A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.

    Distribution

    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

    Quantity

    1,096 Units (total for all products)